Ranbaxy gets tentative nod from US for tamsulosin

New Delhi, June 22: Pharma major Ranbaxy Laboratories Ltd (RLL) today said it has received tentative approval from the US Food and Drug Administration (US FDA) to manufacture and market tamsulosin hydrochloride capsules (HCL).

Tamsulosin HCl capsules is used to treat benign pro static hyperplasia. The annual market sales in US for Flomax(r), Tamsulosin HCl capsules were 1.1 billion dollars, a company statement said.

''We anticipate introducing this formulation with a 180-day period of exclusivity assuming the successful resolution of the patent litigation regarding this product,'' Jim Meehan, vice-president of sales and marketing, Ranbaxy Pharmaceuticals Inc (RPI) said.

US-based RPI, a wholly-owned subsidiary of Ranbaxy Laboratories Limited (RLL), is engaged in the sale and distribution of generic and branded prescription products in the US health care system.

RLL, headquartered in India, is an integrated, research-based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by health care professionals and patients across geographies.

Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary ''platform technologies'', resulting in a number of products under development.

The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 11 countries.

UNI